Wednesday, August 02, 2006

A magical mystery tour of NCCAM chelation study sites---part 1

On first learning of the National Center for Complementary and Alternative Medicine’s Trial to Assess Chelation Therapy (TACT) I was optimistic that it would settle the chelation controversy once and for all. But examination of the TACT web pages raises concerns about the quality of the study. The scientific integrity of many of the research sites is questionable. Only 12 of the 110 study sites are located in academic medical centers. Worse, a substantial number appear to be engaged in dubious practices, making pseudoscientific and even fraudulent health claims. This is the first in a series of posts in which I will profile some of the questionable NCCAM study sites involved in TACT.

What is important about a study site? The investigators must be knowledgeable in the scientific underpinnings of the question being studied. Skills in the methodology of clinical research are important. The investigators must be honest, and conflicts of interest must be addressed. As you read my descriptions of the study sites in the posts that follow, keep these points in mind.

Can the overall study quality be any better than that of the individual sites? An argument could be made that because the study is double blinded, it would be shielded from bias that may exist at individual sites. A close reading of the TACT protocol, however, reveals that the blinding is not secure. First of all, the chelation mixture is not stable and therefore must be mixed at the local site. The ascorbic acid which must be injected into the mixture is yellow in color and highly viscous. The work around for this problem is to cover ascorbic acid, chelation mixture and placebo syringes and bags with tinted translucent tape and to add concentrated dextrose solution to the placebo syringe to make it as viscous as the ascorbic acid.

At the very least, the study conditions which I will point out raise serious questions about the validity of the trial.